I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
Connect with me on
Head of Quality
Dublin West
QA Manager Biologics
Dublin West
QA Manager
Meath
R&D Engineer
Galway
API Purchaser
Dublin
QA Officer
Dublin
Program Manager
Westmeath
Biostatistician
Dublin City Centre
R&D Engineer
Dublin
Buyer
Cork
Snr QA Specialist
Dublin South
QA Manager
Dublin North
QA Manager
Dublin West
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Process Development Engineer


Reference:JCACDY-252105 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed


Process Development Engineer

In support of its ongoing medical device development programme, our client currently requires a Process Development Engineer, to support product and process development activities

Role/Responsibilities

• Development of Class III medical devices and associated manufacturing processes, entailing:
o Device development based on outputs from product/process improvement feedback
o Process development to facilitate manufacture of product, including implementing appropriate process controls
o Development and validation of test and inspection methods
o Requalification of devices and processes to support change implementation
o Training of operators on developed processes
• Development of project documentation, with focus on detail and quality
o Product specifications
o Detailed product/tooling drawings
• Generation and maintenance of manufacturing documentation (Manufacturing strategies, Process Flows, DMR, DHR)
• Development and updates of Risk Management documentation through entire product lifecycle
• Planning and execution of verification and validation activities, including
o Procurement of capital equipment
o Assisting in the generation of Validation Master Plans
o Generating verification / validation protocols and reports
o Execution of Equipment Validations (IQs/OQs) and subsequently Design Verification and Process Validation (OQ / PQs)
• Assist in managing vendor quality and providing technical support
• Support Regulatory Affairs with submissions

Skills/Experience:

• Third level degree in Mechanical, Manufacturing or Production Eng or similar discipline
• Min. 3 years experience in product / process development, ideally in Class II / III medical devices
• Design Skills involving 3D modelling
• Experience designing jigs and fixtures and developing automated processes
• Knowledge of materials and processing techniques (polymers, metals, ceramics), including rapid prototyping
• Knowledge of manufacturing processes within a clean-room environment
• Attention to detail and Quality Focus
• Strong communication skills



James Cassidy | Tel: +353 (0) 1 5079250